Breast Augmentation remains one of the most frequently performed cosmetic plastic surgery operations. While the procedure remains the safest and most reliable means of Breast Enlargement, from time to time, patients may require Breast Augmentation Revision Surgery.
Saline Breast Implant Deflation Replacement Before and After Pictures
Saline Breast Implant Deflation Replacement Before and After Pictures – On the left, this patient’s saline breast implant has clearly deflated. On the right, after breast augmentation revision surgery, both breast implants were replaced and the breasts are now rejuvenated. A great time to consider changing the size, style or type of breast implant is when you need to replace a deflated device.
Breast Implant Revision Video Presentation
Today’s Plastic Surgery Video outlines several of the most common Breast Implant Revision Surgeries, and illustrates what is possible with numerous Breast Augmentation Revision Before and After Pictures. My segment segment first aired on, the San Francisco Bay Area’s news station KRON 4’s Body Beautiful. I have made numerous appearances during the show’s 12-years run, I have had the opportunity to inform millions of viewers about the pros and cons of Cosmetic Plastic Surgery.
Breast Revision Surgery Video Presentation as seen on KRON 4’s Body Beautiful
Breast Augmentation Revision Surgery
Breast Augmentation Revision Surgery for Capsular Contracture – Before and After Pictures show treatment of capsular contracture of this patient’s right breast implant. The results are improved symmetry, softness and patient satisfaction.
The majority of patients do not require revision surgery; however, Breast Implants are not considered lifetime devices. As such, they may require maintenance. The care of Breast Augmentation patients has become a specialty unto itself. Breast Augmentation Revision encompasses a variety of procedures including surgeries to adjust breast implant size, soften capsular contracture, reposition implants that have shifted and replace implants that have ruptured.
Breast Implant Revision Surgery for Symmastia – Before and After Pictures. This patient developed symmastia, uni-boob or breast-loafing of her breast implants. Before correction, she had breast implant malposition with both symmastia and bottoming-out. After breast revision surgery, her breasts are separated and elevated to a more aesthetic position.
Breast Augmentation Revision Surgery Consultations
Breast Implant Revision is an important aspect of maintaining Breast Augmentation aesthetics. Like primary Breast Augmentation, careful attention to detail is necessary. If you are considering Breast Implant Revision surgery, be certain to consult with an experienced and Board Certified Plastic Surgeon. In the San Francisco Bay Area, call (925) 943-6353 to schedule your private consultation appointment.
Breast Implant Revision Surgery is performed when there is a problem with the breast implants. Some problems are subjective, for example when the implants are judged to be too small or too large. Other problems are objective, such as issues with the breasts’ shape, firmness, symmetry or position. These are commonly associated with Capsular Contracture and breast implant malposition. A third group of breast implant problems require urgent attention, like infections or exposure of the breast implants.
Today’s post reviews Breast Revision Surgery and the treatment for some of the more common Breast Augmentation Problems.
Capsular Contracture Correction
Capsular Contracture occurs when the normal pocket that holds the breast implant in place becomes tight. It can be tight all around the implant causing firmness and a reduction in the apparent size of the implant(s), or it can be along one side, pushing the implant out of position, usually upward.
These breast augmentation revision before and after pictures show grade III/IV capsular contracture of the right breast preoperatively, and the result of removing the tight capsule (capsulectomy) thus lowering the breast mound to match the left side. (Click image for uncensored view.)
In the Breast Implant Revision Before and After Pictures above, the right breast mound is significantly higher, and harder, than the normal appearing left breast mound (Grade III Capsular Contracture). This is a problem for the patient both in and out of clothing, and with time, the right breast has become tender (Grade IV Capsular Contracture).
This Breast Implant Malposition was treated with a complete capsulectomy, removal of the tight scar. The result is a softer breast, that is lowered back to its normal and symmetrical position. The areolae are also more symmetrical postoperatively. To see the nipple position, click or touch the picture above and the censoring will be removed. Tap again to replace it.
Symmastia Correction for Uniboob
Symmastia is a specific type of Breast Implant Malposition where the implant(s) move toward the midline. It is more common in women with tighter skin and larger, high profile breast implants. Just like raising the towers on the Golden Gate Bridge would raise the bridge’s cables across the mouth of the San Francisco Bay, the high profile breast implants have raised the skin across the sternum causing a Uniboob Deformity or “Bread Loafing”. In addition, this patient has “bottoming-out” of her breast implants, greater on her right side.
These breast augmentation revision before and after pictures show symmastia of the breasts and bottoming out (right greater than left) preoperatively. The after photo shows the result of symmastia repair and breast implant replacement with smaller breast implants and raising of the inframammary folds (IMFs) thus getting rid of the uniboob bread-loafing of the implants in the midline. (Click image for uncensored view.)
The Symmastia Deformity was corrected by both repairing the damage and addressing the original problem to prevent recurrence. The damage was repaired by closing the original capsule medially, forming a pseudoneopocket in the correct anatomical position and reinforcing the repair. Since the original cause was breast implants too large for the chest, they were replaced with smaller implants. The after picture shows that the breasts have been elevated and separated into two separate breast mounds. Breast symmetry is improved and the reduction in breast implant size should help to maintain the superior cosmetic result.
Stage 1 – Breast Implant Removal for Impending Exposure
Breast Implant Exposure and Breast Implant Infections are emergencies, and require prompt surgical intervention. In the picture below, the square area at the base of her left breast is the lower edge of the breast implant which is about to erode through the breast skin. Once exposed, infection is inevitable, so the implant was removed promptly to prevent this eventuality.
These breast augmentation revision before and after pictures show stage one of treatment for breast implant exposure. Once an implant is exposed, it requires removal to prevent infection and sepsis. The after photo reveals that the left breast was smaller before breast augmentation, confirmed by the removal of a larger breast implant during surgery. (Click image for uncensored view.)
An inframammary incision was used to remove the breast implant, and the damaged skin at the base of the breast was also removed to allow for a secure closure. Her left breast implant was larger than the right, because her left breast was smaller than her right breast before Breast Augmentation. The size discrepancy is apparent in the after picture
Stage 2 – Breast Implant Replacement after Exposure
After breast implant infection or exposure, a minimum of three months is allowed to pass before replacing the breast implant. This is to reduce the risk of another infection. After three months, the patient returned to the operating room for delayed Breast Implant Replacement.
These breast augmentation revision before and after pictures show stage two of treatment for breast implant exposure. After the breast implant is removed, and the site heals for several months, the breast implant can be replaced. The after photo shows the restoration of symmetrical breast mounds after Asymmetrical Breast Augmentation. (Click image for uncensored view.)
The before and after pictures above show the results of the second stage of reconstruction. The breast implants were replaced without complications, and the patient was happy to have her figure back.
Breast Implant Removal is performed for about 1% of all Breast Augmentation patients. It is not a common procedure. Often it is elective, but sometimes it is as necessary as it is unwanted.
These breast implant removal before and after pictures show the result of removing moderate sized breast implants from a woman with young, elastic skin. No lift was needed. (Click image for uncensored view.)
Why Breast Implants Are Removed
Breast Implant Removal is chosen for many reasons ranging from completely elective to emergency situations. Elective reasons include the desire to have smaller breast, anticipating pregnancy and breast feeding and even a desire to exchange the current breast implants for larger ones. Urgent situations include exposure and infection of the implants.
How Are Breast Implants Removed?
These breast implant removal before and after pictures show the result of removing ptotic, “bottomed-out” breast implants with a Breast Lift performed at the same time. (Click image for uncensored view.)
Breast Implants are often removed during a relatively short outpatient procedure through the same incisions originally used to place them.
For Saline Breast Implants, after a small incision is made the implants are deflated and then removed. The empty shell allows removal through a smaller incision.
Silicone Breast Implants are not deflated prior to removal to avoid leaving silicone inside the breasts. If silicone breast implants are already ruptured, the capsule is often removed to contain the extravasated silicone and to prevent gel migration.
Breast Implant Removal Recovery
These breast implant removal before and after pictures show the result of removing large breast implants from breasts with less elastic skin. No lift was performed, so the skin sags after the loss of support previously provided by the breast implants. (Click image for uncensored view.)
Recovery after Elective Breast Implant Removal is normally just a few days. If a capsulectomy is performed, a drain is often placed, and it may take longer for the swelling to subside. Aesthetically, the appearance of the breasts continues to improve for several months as the skin recoils postoperatively.
BioCell® Textured Breast Implants
Since the recall of BioCell® Textured Breast Implants a few weeks ago, I have received several phone inquiries regarding breast implant removal. This textured surface is associated with a small risk of developing BIA-ALCL; however, the FDA’s current recommendation is to leave the implants in place and follow them clinically for signs and symptoms including enlargement due to fluid collections around the implants and swelling.
Despite the FDA’s current recommendations, some patients feel more comfortable having their BioCell® textured breast implants removed or replaced. Allergan® will provide smooth replacement implants at not charge (until July 24, 2021). Since the FDA does not recommend removal, there is no financial support available for the elective surgical removal of BioCell® textured breast implants.
Breast Implant Removal Consultations
If you are considering elective Breast Implant Removal, be certain to consult with an experienced and Board Certified Plastic Surgeon. In cases with larger implants and skin laxity, a Breast Lift may be recommended, either at the time of breast implant removal or staged after recovery.
An experienced plastic surgeon can discuss these and other options with you and offer personalized guidance during an in-person consultation appointment. To schedule a private consultation in our Walnut Creek plastic surgery office call (925) 943-6353.
This month, Allergan® has updated their warranty for the affected BioCell® Textured Breast Implants. The following information comes directly from Allergan®, and is correct at the time of publication. As with any warranty, be sure to check with Allergan® directly if you have questions about their products.
What Implants Are Covered?
The BioCell® Replacement Warranty covers all BioCell® textured implants that were manufactured under the brands McGhan®, Inamed®, Allergan® or Natrelle®. Both saline and silicone gel-filled textured implants are covered. This coverage will be available through July 24, 2021. Please note that Natrelle® smooth breast implants are not subject to this withdrawal.
What Are The Replacement Options?
The FDA web site has up-to-date breast implant and BIA-ALCL information.
The FDA recommends not to remove devices if you do not have symptoms. However, if you and your plastic surgeon decide that replacing your device(s) is in your best interest, you can choose any Allergan® smooth breast implant(s) as a replacement on or before July 24, 2021.
You should bring your current patient ID card or any other information available about your implants with you to your appointment. You and your plastic surgeon will decide on the best size and style as a replacement option for you. Your plastic surgeon will request your replacement implants from Allergan® on your behalf.
Are Surgery Fees Covered?
No. As part of this program, Allergan® will not provide surgical fee assistance. This decision is aligned with the FDA’s recommendation not to remove textured implants or other types of breast implants in patients who have no symptoms of BIA-ALCL.
What If I DO NOT Explant My Textured Implants?
If you choose not to explant your BioCell® textured devices, you will continue to be covered under the Natrelle® ConfidencePlus® Warranty, which includes comprehensive coverage including rupture, capsular contracture and late seroma. More information about the Natrelle® ConfidencePlus® Warranty can be found at Allergan.com.
How Do I Know If My Implants Are Textured?
Allergan Smooth and Textured Breast Implants
Most breast implants used world-wide are Smooth Breast Implants. All teardrop shaped implants are textured, so if you have teardrop shaped breast implants, you have textured implants. For Allergan®, these are called style-410. Some round implants are textured. You will need the catalogue number for your breast implants to know if they are textured.
Please visit Allergan.com to understand how to read your product ID card. If you don’t have a card, or would like to speak to someone at Allergan, please contact Allergan Medical Information at 1-800-678-1605, option #2, or email IR-Medcom@allergan.com.
How Do I Learn More About BIA-ALCL?
I am constantly updating my blog with new information about BIA-ALCL and other Plastic Surgery News. So keep tuned to the San Francisco Plastic Surgery Blog for more information. Additional reading is available on the FDA Website.
Textured Implant Removal or Exchange Consultations
If you are concerned about your breast implants and are considering changing size or style, be sure to consult with a Board Certified Plastic Surgeon near you. In the San Francisco Bay Area, call our Walnut Creek Plastic Surgery Center at (925) 943-6353 to schedule your appointment.
Today, Allergan® voluntarily withdrew all BioCell® Textured Breast Implants and Tissue Expanders from the world markets due to an association with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Allergan® Biocell® textured breast implants have the highest association of BIA-ALCL.
Textured Breast Implants and BIA-ALCL
I have been posting about an association of BIA-ALCL and textured breast implants for some time here on the San Francisco Plastic Surgery Blog. While many types of textured breast implants exist, a higher association of BIA-ALCL has been found with more aggressively textured breast implants. Allegan® has the most aggressively textured breast implants and thus the highest association with BIA-ALCL.
BioCell® Textured Breast Implants and BIA-ALCL
BioCell® textured surface (shell) is a unique surface used only by Allergan®. A detailed list of the specific BioCell® textured devices marketed in the U.S. that are recalled can be found at the end of this post.
The FDA’s analysis was attributed to a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan® textured breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan® textured breast implant at the time of their BIA-ALCL diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.
The risk of BIA-ALCL with Allergan® BioCell® textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other U.S. manufacturers.
BIA-ALCL Is Not Breast Cancer
Early treatment is the key to the cure for BIA-ALCL as it is for any medical illness. When in doubt; check it out.
BIA-ALCL is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. At this time, the overall incidence of developing BIA-ALCL is considered to be low; however, a BIA-ALCL diagnosis is serious and can lead to death, especially if not diagnosed early or promptly treated. In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant; however, some patients may require treatment with chemotherapy and/or radiation therapy.
BIA-ALCL Is Rare
It is important to understand how rare the occurrence is and put the numbers into perspective. Literature indicates the current lifetime risk is about 1 in 20,000 patients with textured implants. BioCell® has a 7x to 8x greater incidence of BIA-ALCL compared to all other manufacturers’ textures, including Sientra® Texture and Mentor® Siltex. Geographic regions also reported variable risks including: Australia 1 in 3,345 for BioCell® and 1 in 86,029 for Siltex. In 2018, over 400,000 women underwent breast augmentation and reconstruction with implants in the U.S. Here are some comparative rates from the Sientra website:
The average woman’s risk of developing breast cancer in her lifetime is 12.5%. This means that 1 out of 8 women may develop breast cancer in her lifetime.
The risk of developing recurrent breast cancer after mastectomy is 5-8%. This means that 5 to 8 out of 100 women may develop recurrent breast cancer after mastectomy.
The risk of capsular contracture through 10-years is ~14%. This means that 14 out of 100 patients may experience capsular contracture within 10 years after receiving implants.
The risk of breast implant rupture through 10-years is ~8%. This means that 8 out of 100 patients may experience implant rupture within 10 years after receiving implants.
The risk of developing BIA-ALCL from a textured breast implant is ~0.005%. This means that 1 out of 20,000 women with textured implants may develop BIA-ALCL.
FDA Is Not Recommending Removal Of Textured Implants
To date, the FDA has not recommended removal of textured breast implants, including those with Allergan®‘s BioCell® texturing.
From the FDA website:
If you have no symptoms, we [the FDA] are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL.
Know the symptoms of BIA-ALCL – primarily persistent swelling or pain near the breast implant – and monitor the area around your breast implants for any changes.
Evaluation for BIA-ALCL typically involves a physical exam, imaging, and/or assessment of the fluid or tissue around the breast implant. It is important to undergo an evaluation to diagnose BIA-ALCL since a confirmed BIA-ALCL diagnosis may change the type of operation that should be performed.
Based on discussions with your healthcare provider, patients with confirmed BIA-ALCL should undergo implant removal and removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone.
As with any implanted device, it is good to keep a record of the device manufacturer, unique device identifier, and implant model name. You may have received this information on a patient device card from your surgeon. If you would like to obtain any of this information, consider asking your surgeon or obtaining the record of your surgery (operative notes) from the facility where it was performed.
Understand that most cases of BIA-ALCL occur many years after breast implant placement
If you have any questions, talk to your healthcare provider.
The FDA understands that today’s action may cause concern to patients who have breast implants, especially those who know they have one of the listed Allergan® BioCell® model implants or may not know the implant’s manufacturer or model. The FDA continues to monitor and evaluate reports of adverse events in databases, including external patient registries, and in scientific literature for the incidence of BIA-ALCL across all breast implants and other devices intended for use in the breast. The FDA further notes that the macro-textured implants, like the BioCell® textured implants manufactured by Allergan®, represent less than 5% of breast implants sold here in the U.S. In fact, textured implants account for only 10% of all breast implants sold in the U.S. To fully understand your risk of developing BIA-ALCL, the FDA recommends that patients and healthcare providers follow the FDA’s recommendations stated above. More information about BIA-ALCL can be found on the Breast Implants webpage. Additionally, the FDA will continue to update the public about developments in this area.
List of Affected BioCell® Products
Allergan® Natrelle Textured Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074. The following are the textured styles:
Style 163 – BioCell® Textured Shaped Full Height, Full Projection Saline Breast Implants
Style 168 – BioCell® Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)
Style 363 – BioCell® Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan® catalog includes 363LF, or 363 Low Height Full Projection
Style 468 – BioCell® Textured Shaped Full Height Moderate Projection Saline Breast Implants
Allergan® Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants) approved under P020056. All the new Natrelle Inspira BioCell® textured breast implant style numbers start with “T”. If your Allergan® Natrelle Inspira breast implant style starts with “S”, they are smooth, and are not part of this withdrawal. The following are the textured styles:
Style 110 – BioCell® Textured Round Moderate Projection Gel Filled Breast Implants
Style 115 – BioCell® Textured Round Midrange Projection Gel Filled Breast Implants
Style 120 – BioCell® Textured Round High Projection Gel Filled Breast Implants
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants approved under P040046. All style 410 implants are BioCell® textured. The following are the textured styles:
Style 410 MF
Style 410 FL
Style 410 ML
Style 410 LL
Style 410 LM
Style 410 LF
Style 410 FX
Style 410 MX
Style 410 LX
Allergan® tissue expanders for the breast that have BIOCELL texturing originally cleared as:
Natrelle 133 Plus Tissue Expander (K143354)
Natrelle 133 Tissue Expander with Suture Tabs (K102806)
What To Do?
If you don’t know what breast implants you have, find out. All my patients are given a card with their implant information to keep in a safe place. If your surgeon did not give you this information, or you can’t find it there are options. You can
call you surgeon’s office
contact the surgery center or hospital where you had surgery
contact the breast implant manufacturer
90% of the breast implants used in the U.S. are smooth and are not affected by this action. In my office, we have always preferred the results obtained with smooth breast implants. Less than 1% of the implants I have placed are textured, and not all of them are Allergan®. In fact, in my over 20 years of practice, I have removed more textured breast implants than I have placed. If you had your breast augmentation with me, and are wondering which implants you have, your breast implant card should state whether your implants are smooth or textures. If you don’t have your card, just give us a call and we will look it up.
If you have Allergan® BioCell® textured breast implants, don’t panic. Your risk of developing BIA-ALCL is still very low. If you are asymptomatic, the current recommendation is to leave them alone, and monitor for changes. If you have changes, do not delay in getting evaluated by your doctor. The most common presentation is an increase in size of one breast years after breast augmentation, usually due to a collection of fluid around the breast implant (seroma). While, most seromas are not due to BIA-ALCL, all should be investigated. If you have any concerns, contact your plastic surgeon for more detailed information.
Breast Augmentation Revision for Capsular Contracture. Notice the decreased volume, increased hardness and irritated red color in the before picture on the left. After release, the breast are softened and expanded. (To view uncensored before and after photos, click on the image.)
Breasts sagging off implants (Waterfall deformity)
One of the most common reasons for Breast Implant Revision Surgery is Capsular Contracture. So what is the capsule and what is contracture?
When you have Breast Augmentation, a pocket is created for the breast implant behind the native breast tissue. As this pocket matures, your body creates a thin layer of scar around the breast implant. This scar pocket is called the capsule, and it is very important because the capsule holds the breast implant in place, preventing it from migrating. Capsular Contracture occurs when the scar lining the breast implant pocket contracts, squeezing and distorting the breast implant.
Capsular contracture often affects just one side. In the case above, the right breast implant is higher and tighter than the left before surgery. After surgery symmetry is restored. (To view uncensored before and after photos, click on the image.)
The above patient has mild capsular contracture affecting only her right breast. She was able to compensate for the difference in upper pole fullness by tightening her left bra strap. During the Breast Augmentation Revision, a capsulotomy was performed to expand the right breast capsule and lower the right breast implant.
Grades of Capsular Contracture
A scar around the breast implant is normal. Without the scar pocket, the breast implant will bottom out and move to the sides. On the other hand, too much scar causes problems with implants riding too high or becoming too hard.
Capsular Contracture is normally classified into four grades (I-IV), but I like to add grade zero for malposition problems caused by not enough scar support.
Grade 0 – not enough support causing breast implant malposition
Grade I – normal soft
Grade II – firm but no visible distortion of breast shape
Grade III – hard causing visible distortion of the breast shape
Grade IV – like grade III but is also painful
Severe unilateral capsular contracture – The right breast so high that it would be hard to disguise in clothing. After treatment for capsular contracture, the breasts are much more even. (To view uncensored before and after photos, click on the image.)
The patient above has severe contracture of the right breast, which was noticeable both in and out of clothing. A capsulectomy was performed to remove the previous capsule, expand the pocket, lower the breast implant and reset the formation of a new capsule. Now both her breasts are soft and even.
Breast Implant Revision
If you have Breast Implants but are unhappy with their size, placement or firmness, Breast Implant Revision is worth considering. To schedule a private consultation, call (925) 943-6353, today. Breast Implants have changed in the last few years, and there are new options available.
Textured Breast Implants will remain available in the U.S. for now.
Lately, it seems there is a new announcement every month regarding BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma). Clinical data continues to be collected and compiled, in no small part thanks to the efforts of the members of the ASPS (American Society of Plastic Surgeons) and the ASAPS (American Society for Aesthetic Plastic Surgery). BIA-ALCL is rare, so there are not many cases available to evaluate.
Most Breast Implants Are Smooth
There seems to be an association between the roughness of texturing and the presentation of BIA-ALCL. Most cases of BIA-ALCL are associated with textured implants. Most breast implants used are smooth. In the US database, all patients with BIA-ALCL had textured breast implants at one point in their history. The question remains why is there an association. Unfortunately, in order to answer this question, more data is needed.
The French Rejection
Last month, as reported here in the San Francisco Plastic Surgery Blog, the French authorities (ANSM) decided to withdraw all macrotextured breast implants and polyurethane-coated breast implants from the market. The decision was criticized by many medical professional organizations for being one-sided, based on incomplete information and neglecting to take into account the benefits that textured implants offer to selected patients.
The U.S. Confirmation
Yesterday, the U.S. FDA spelled out the reasons why textured breast implant will remain on the market in the U.S.. Excerpts from the announcement are included below, but first, what do we currently know, and what are these decisions being based upon?
Pros & Cons of Textured Breast Implants
Everything we do as doctors has pros and cons, but the decision to weigh risks and benefits should remain individualized and between doctor and patient. When there is clear evidence that a device or a medicine causes more harm than good, only then does complete removal from the market seems warranted.
Smooth breast implants are a good alternative (if not superior) in most cases. In my practice, I use smooth, round, breast implants more than 90% of the time. However, there are two situations in which textured implants may provide an advantage: breast reconstruction and capsular contracture.
Textured Implants and Breast Reconstruction
After a mastectomy or for some congenital breast abnormalities, shaped breast implants provide a superior cosmetic result. In these cases, the lower pole of the breast is tight and resists expansion. By placing an implant which is fuller at the bottom, the lower pole can be filled more than the top, creating a better shape and a more normal appearance.
The concept is simple; however, keeping the implant from spinning is not. The original breast implants from the 1960’s used fuzzy patches on the back to anchor them and prevent rotation. The problem was the implant would tear at the attachment and leak.
Internally stacked implants attempted to provide the same cosmetic results without the external patches. These where normal silicone gel filled implants, but had smaller implant placed inside them to fill the lower pole. The internal implant was anchored inside the main implant to keep extra filling in the bottom, creating the desired tear-drop shape. The result were beautiful. Unfortunately, the internal fixation caused the same problem as the original external patches, and the implants ruptured at ten times the usual rate.
Today’s shaped implants are textured to help prevent rotation. The rough surface attaches to the surrounding tissue a bit like velcro, making it less likely to spin. This too is not perfect, but to date, it’s the best method we have to keep the big end of the implant in the lower part of the breast. Without texturing, the teardrop shaped implant spins, giving up-side-down looking breasts, dilating the pocket and causing implant malposition.
Texturing and Capsular Contracture
Texturing has also been shown to reduce the incidence of Capsular Contracture. Capsular Contracture is caused by contraction of the capsule that normally holds the breast implants in place. As is tightens the breast can become firm and the breast implants can move. Revision surgery is usually necessary to reposition the breast implants and soften the breasts. Textured breast implants have a lower risk of capsular contracture, but come with a higher risk of visual rippling (wrinkling). More about capsular contracture and its treatment can be found on my website’s Capsular Contracture Page and Breast Augmentation Revision Page.
U.S. Food & Drug Administration
Yesterday, the FDA announced that textured breast implants would remain on the U.S. market.
The announcement is framed by the opening paragraphs:
There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s an issue that has been a priority for us at the U.S. Food and Drug Administration since 2011 when we warned women that the available information at the time indicated that there is a risk for women with breast implants, especially those with textured implants, for developing this disease.
Since that time, we have worked diligently to fill the gaps in knowledge, such as evaluating the body of available evidence regarding the safety and risks of breast implants, including concerns specific to textured implants and the risk of BIA-ALCL. The agency has undertaken several steps to better understand this issue, including an in-depth review of post-approval study data, medical device reports, scientific literature and breast implant-specific registries, and public discussions.
Steps the U.S. FDA is Taking
The FDA announced specific steps they will be taking to better understand the disease and share the information collected.
First, we will take steps to improve the information available to women and health care professionals about the risks of breast implants that would include addressing the risk of BIA-ALCL, the greater risk of BIA-ALCL with textured implants, and the risk of developing systemic symptoms that would contribute to the patient-provider discussion about breast implants. We are also looking at ways to incorporate product ingredient information into the labeling in a way that is easy for patients to understand. The FDA would work with stakeholders, including patient groups, on the content and format of any labeling changes proposed or recommended by the FDA, which could include a boxed warning and a patient decision checklist, and would work with manufacturers on implementing any changes to the information they provide to health care professionals and patients, including labeling.
We will continue our regular updates about the known global medical device reports for BIA-ALCL, as we have done since 2011. Moving forward, we plan to also regularly communicate information we receive through medical device reports about systemic symptoms experienced by patients with breast implants. We provided information at the two-day advisory committee meeting on medical device reports we’ve received that mention systemic symptoms described by some as breast implant illness, and we plan to continue sharing the numbers of medical device reports on these symptoms.
The FDA has been in the process of changing how adverse events are reported. In the past summary reporting was allowed, but this is being phased out for breast implants, and all medical devices.
Moving forward, breast implant manufacturers will be required to file individual medical device reports that will be publicly available in MAUDE. For past data received through summary reporting, the agency will also be making this data, including alternative summary reports for all devices under the program, publicly available in the coming weeks.
New FDA Reporting Requirements
The FDA has also recognized the importance of the American Plastic Surgery Societies registries.
Partnering with registries, such as the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILEExternal Link Disclaimer), which collects real world data on patients with BIA-ALCL diagnoses, and the new National Breast Implant Registry (NBIRExternal Link Disclaimer), which collects real world data on the safety and performance of breast implants, is one way in which we seek to gain greater insight and more comprehensive information about women’s experiences with breast implants.
The FDA Addresses the French Rejection
The FDA also commented on the restriction and banning of textured implants in Europe.
A few of our international counterparts have started to initiate actions to ban or restrict sales of some textured breast implants, based on concerns about BIA-ALCL. In those markets, there are textured implants that are not marketed in the U.S. and where the use of textured implants is much higher, sometimes as high as 80% market share. In 2018, textured breast implants represented less than 10% of breast implants sold in the U.S. The type of macro-textured implants targeted by some of our international counterparts represents less than 5% of breast implants sold here. At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act.
The FDA believes regulatory action must be based on scientific data. While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis. We are focused on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed of the risk of BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low. We are still investigating the cause of the association and we will continue to monitor, assess and report our findings as we continue to strengthen our evidence collected so that women and providers can be better informed about BIA-ALCL as they consider breast implants.
Taken together, we believe these efforts to improve communication and focus on evidence generation will contribute significantly to improving the safety of breast implants and want to share that many of these efforts are already underway. We are committed to making a difference for women’s health and will continue working towards ensuring we understand the benefits and risks of these devices, and that women have the most complete information available to make important breast implant decisions.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
What we know about Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is evolving. We learn more as each new case is identified. Right now, there are just too few cases to know many of the specifics; however, today I will go over the data currently available.
ASPS and ASAPS summary of BIA-ALCL in 2019
Much of this information comes from the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS). Thanks to its members voluntarily reporting and collecting information on BIA-ALCL, these US based national plastic surgery organizations have the best database on BIA-ALCL in the world.
What is BIA-ALCL?
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon and treatable type of T-cell lymphoma that can develop around breast implants. BIA-ALCL is not a cancer of the breast tissue itself. It is not breast cancer, but it is found in the breast, around the capsule which surrounds breast implants.
When Does It Present?
The time between breast implant insertion and diagnosis of BIA-ALCL varies greatly. It ranges from 9 months to 27 years, with an average delay in presentation of 9.2 years.
Who Gets BIA-ALCL?
Cases seem to be concentrated in patients who have, or who have had textured breast implants. It seems to be related to the aggressiveness of the texturing and has occurred in patients with both silicone and saline filled breast implants.
When in doubt; check it out. Early diagnosis and treatment are key to curing BIA-ALCL.
After reviewing all available case series, case reports, and registries, BIA-ALCL is more common with textured implants. Textured implants are used less frequently than smooth implants. Textured implants are also used more often for breast reconstruction after breast cancer, because shaped implants are more desirable in this population and texturing is used to reduce breast implant rotation for shaped implants.
To date, no cases of BIA-ALCL have been verified in patients who have had exclusively smooth breast implants. However, it is not possible to exclude the appearance of BIA-ALCL in association with smooth implants at this time. The FDA reports that they are aware of smooth breast implant only cases; however, they warn that this information is “unverified” and potentially “inaccurate.”
The association of BIA‐ALCL and textured implants may be related to the increased surface area of the texturing; however, this has not yet been definitively proven. The variation in surface texturing among breast implant manufacturers may mean there are variable risks for the development of BIA-ALCL.
How Does BIA-ALCL Present?
The majority of patients present years after their initial surgery with one breast gradually increasing in size. The increased size is from fluid, serum, collecting around the breast implant. This collection of fluid is called a seroma. Seromas are normal right after surgery; however these seromas appears later and are thus called a delayed seromas. A few patients have presented with different symptoms such as a mass, skin rash, fever and night sweats, and lymphadenopathy.
How Is The Diagnosis of BIA-ALCL Made?
BIA-ALCL usually presents as increased breast size due to fluid collecting around a textured breast implant.
Diagnosis is based on analysis of the fluid in the seroma. Most commonly, ultrasound‐guided fine needle aspiration of the peri-implant fluid is assessed with immunohistochemistry for CD30-positive large anaplastic T-cell lymphocytes.
How Is BIA-ALCL Worked Up?
PET‐CT is performed following a positive diagnosis. Mammograms are not helpful for evaluating lymphoma, but are important for the evaluation of breast cancer. Often, a multidisciplinary team approach including, when required, an oncological breast surgeon and an oncologist specializing in lymphoma.
How Is BIA-ALCL Treated?
The treatment of BIA-ALCL is evolving. In most cases, cure is obtained by removal of the breast implant and the capsule surrounding it. Incomplete capsular resection has been associated with both recurrence and significantly lower survival. Rarely, patients may present with a mass and have an increased risk of requiring radiotherapy and chemotherapy. Treatment approach should follow international guidelines established by the National Comprehensive Cancer Network (NCCN) for BIA-ALCL, available at nccn.org.
Current treatment recommendation is for bilateral complete capsulectomy and implant removal, as a small number of women have had contralateral disease found incidentally; however, it cannot be stressed enough that the treatment is still evolving, and each patient must be individually evaluated. If you suspect you have BIA-ALCL, do not delay, and contact your plastic surgeon or primary medical doctor immediately.
Summary Statement On BIA-ALCL From The ASPS
I have included below a statement released by the American Society of Plastic Surgeons (ASPS) this week. It summarizes well what we currently know about BIA-ALCL. The ASPS has also published an 2019 online BIA-ALCL summary.
“Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon type of lymphoma that can develop in the scar capsule near saline or silicone breast implants. This disease is currently being investigated as to its relationship with breast implants. The family of ALCL is a rare cancer of the immune system, which can occur anywhere in the body. Based on adverse event reports, the United States Food and Drug Administration (FDA) estimates the total number of cases of BIA-ALCL to be over 450 cases.”
“It has been noted that the majority of BIA-ALCL patients have a history of a textured-surface device. An exact single-number estimate of the risk for both textured and non-textured implants is not possible with the currently available data. Lifetime risk of BIA-ALCL has been estimated at 1:1,000 to 1: 30,000 for women with textured breast implants, and BIA-ALCL risk is currently under investigation. BIA-ALCL usually involves swelling of the breast at an average of 3 to 14 years after the initial breast implant operation. Most cases were cured by removal of the implant and the capsule surrounding the implant; however, rare cases have required chemotherapy and/or radiation therapy for treatment.”
“Patients with breast implants should be followed by a surgeon over time and seek professional care for implant-related symptoms such as pain, lumps, swelling, or asymmetry. Patients should monitor their breast implants with routine breast self-exams and follow standard medical recommendations for imaging (e.g. Mammography, Ultrasound, MRI). Abnormal screening results or implant-related symptoms may result in additional expenses for tests and/or procedures to properly diagnose and treat your condition. Tests and procedures could include but may not be limited to: obtaining breast fluid or tissue for pathology and laboratory evaluation, surgery to remove the scar capsule around the breast implant, implant removal, or implant replacement.”
All breast Implants create larger breasts. While Silicone Breast Implants are more widely used, Saline Breast Implants still have a role to fill.
Over 90% of today’s Breast Augmentation patients choose Silicone Gel Breast Implants, but Saline Breast Implants still play a role in selected situations. Today, I review the pros and cons of Breast Augmentation with Saline Breast Implants.
Saline Breast Implant Cost Less
Saline Breast Implants cost less than Silicone Breast Implants. Since saline breast implants are easier to manufacture, they cost less. Also, saline breast implants are not pre-filled. The saline is actually inserted during surgery by your surgeon.
Saline Breast Implant Leak Detection
Saline is water with a little salt added to make it as salty as we are, about 0.9% NaCl.
With Saline Breast Implants, leak detection is simple. When they leak, the slightly salty water inside escapes and is quickly absorbed by the body. The result is noticeable deflation, usually occurring overnight. Unlike Silicone Breast Implants, expensive diagnostic imaging, MRI is not needed. Saline Breast Implants are also easier to replace, because only the shell needs to be removed.
Saline Breast Implant Projection
Until recently, Saline Breast Implants provided more projection than silicone breast implants. When saline implants are filled, they become firmer and have more projection. For the same volume, Saline Breast Implants have about 10% more projection. Additionally, Silicone Breast Implants are flat on the back side, while Saline Breast Implants are convex.
Saline Breast Implants are convex on the back, so they give more projection than the flat-backed Silicone Breast Implants for the same volume.
Saline Breast Implant Incision Size
Saline Breast Implants are inserted empty, so the surgical incision is small. They can be collapsed and then filled after they are inserted by way of a filling tube. On the other hand, Silicone Breast Implants come pre-filled, thus they are bigger and require a larger incision for placement.
Saline Breast Implant Drawbacks
Saline Breast Implants feel firmer, tend to ripple (wrinkle) more and move differently than Silicone Breast Implants. For women going up one cup size, there may be enough native breast tissue to disguise the implant. However, for those going from an A-cup to a D-cup, the implant is more palpable, even when the Breast Implant is placed behind the muscle.
Breast Augmentation Consultation
The difference between Saline and Silicone Breast Implants is just one consideration before Breast Augmentation surgery. While the Internet can provide general information, consulting with an experienced, Board Certified Plastic Surgeon will help you translate which options will work best for you.
If you are in the San Francisco Bay Area, call (925) 943-6353 today, and schedule a private Breast Augmentation Consultation.
Every few years, the US FDA approved breast implant manufacturers update their Breast Implant Warranties. While implant deflation has been covered for a long time, the warranties now include extended coverage for breast implant replacement and enhanced coverage for specific situations that may occur after Breast Augmentation with Silicone Gel Filled Breast Implants. Expanded coverage now includes Capsular Contracture, late seroma formation, double capsule formation and BIA-ALCL.
Below, I compare warranties offered by the three US breast implant brands: Allergan, Sientra and Mentor, in the three major areas of coverage: Capsular Contracture, Rupture and Seroma Formation. It is important to state that these are the current offerings, and that they may change without notification. You should check with the manufacturer directly for the latest warranty information. Additionally, newer coverage is limited to newer implants, so you need to know the manufacturer, type of implant and the date of your surgery in order to determine which warranty applies to your implants.
Capsular Contracture Coverage
The most common reason for Breast Augmentation Revision Surgery is Capsular Contracture. In the breast implant 10-year follow-up studies, occurrence rates ranged from 12% to 19% for the primary breast augmentation cohort. Breast Implant manufacturers have begun to include Capsular Contracture in their warranty programs.
Capsular Contracture is tightening of the scar pocket that holds the breast implant in place. In the left before-photo, Capsular Contracture elevates this patient’s right breast implant and causes severe asymmetry. The right after-photo shows correction after capsule surgery and breast implant revision surgery. Capsular Contracture is now covered by all three US FDA approved manufacturers’ warranties.
Sientra currently offers the best free warranty for Capsular Contracture (grade III or IV). The latest Sientra Platinum20 Warranty offers twenty years of free implant replacement during surgery for Capsular Contracture along with $2000 of financial assistance if capsular contracture occurs in the first two years after surgery.
The Allergan ConfidencePlus Warranty was just updated and is a close second with ten years of free implant replacement during surgery for Capsular Contracture along with $2000 of financial assistance if capsular contracture occurs in the first two years after surgery.
The MentorPromise Warranty offers ten years of free implant replacement during surgery for Capsular Contracture, but no financial assistance. However, Mentor does offer an enhanced warranty. You need to pay $300 to Mentor at the time of your surgery to obtain the MentorPromise Enhanced Warranty. This includes ten years of free implant replacement during surgery for Capsular Contracture and $3500 of financial assistance but limits coverage to primary augmentation or primary reconstruction unless MemoryShape breast implants are utilized. Mentor currently lags, especially when comparing the free warranties; however, Mentor may update their warranty to more closely match their competitors as Allergan did when Sientra announced enhanced free coverage for capsular contracture.
These Breast Implant Rupture Before and After photos illustrate a common case of Breast Implant Revision Surgery. The coverage is variable and depends on the manufacturer.
All three manufacturers provide free lifetime breast implant replacement on both sides and financial assistance for the revision surgery. Recently, Sientra increased the financial assistance offered, and it remains to be seen if the other manufactures will match them, as they often do.
The Sientra Platinum20 Warranty offers $5000 in financial assistance toward replacing the breast implants for up to 20 years after the original surgery. This is a recent change and is currently the best in the industry.
The Allergan ConfidencePlus Warranty offers $3500 in financial assistance toward replacing the breast implants for up to 10 years after the original surgery.
The MentorPromise Warranty also offers $3500 in financial assistance toward replacing the breast implants for up to 10 years after the original surgery. This is not increased in the MentorPromise Enhanced Warranty.
Late Seroma Coverage
As shaped implants became more popular, so did the problems associated with them. Shaped implants can rotate and “change” shape. To reduce this problem, shaped implants are textured. This can help prevent rotation and may also reduce the risk of capsular contracture; however, Textured Breast Implants also have unique problems: seromas (collections of fluid around implants), double capsules and possibly BIA-ALCL. Manufacturers have responded with late seroma coverage along with coverage for double capsules and BIA-ALCL diagnostic testing in their latest Breast Implant Warranties.
Seromas are collections of fluid. Small amounts of fluid around the breast implants is normal the first few days after surgery and resolves spontaneously. Seromas that appear years after surgery are not normal or common. The fluid will enlarge the effected breast, making it appear larger than its sister breast. It may present as the picture above shows, with the right breasts appearing larger than the left. There are many causes, most of them benign; however, all should be checked by your plastic surgeon. Breast implant warranties are starting to include testing and treatment for late seromas.
The Sientra Platinum20 Warranty provides twenty year coverage for breast implant replacement and $2000 in financial assistance should a double capsule or seroma form in the two years after surgery. They also provide CD30 panel testing for BIA-ALCL evaluation of late seroma fluid.
The Allergan ConfidencePlus Warranty also was recently updated to provide twenty year coverage for breast implant replacement and $2000 in financial assistance should a double capsule or seroma form in the two years after surgery. They also provide up to $7500 in financial assistance and implant replacement in cases of BIA-ALCL.
The MentorPromise Warranty offers ten year coverage for breast implant replacement and no financial assistance in cases of double capsule and seroma formation. However, Mentor does offer an enhanced warranty. You need to pay $300 to Mentor at the time of your surgery to obtain the MentorPromise Enhanced Warranty. This includes ten years of free implant replacement during surgery for Capsular Contracture and $3500 of financial assistance in the ten years after surgery. Like the Mentor Capsular contracture coverage, coverage is limited to primary augmentation or primary reconstruction unless MemoryShape breast implants are utilized. There is currently no coverage for BIA-ALCL testing.
Breast Augmentation and Breast Augmentation Revision
If you are considering Breast Augmentation or Breast Augmentation Revision, be certain to ask your Board Certified Plastic Surgeon about breast implant warranties. For revision surgery, bring as much information as possible about your current implants to your consultation appointment. The breast implant card given to you after surgery is very helpful as it provides the manufacturer, size, type of implant, and date of implantation.
There is much to know about Breast Implants and the procedures used to place and maintain them. It helps to have an experienced guide to answer your questions and provide expert guidance. For Breast Augmentation and Breast Augmentation Revision in the greater San Francisco Bay Area, call (925) 943-6353 today, to schedule a private consultation.